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Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection (SEVO-COVID19)

Primary Purpose

Acute Respiratory Distress Syndrome, COVID19 Infection

Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Sevoflurane
Propofol
Sponsored by
Fundación para la Investigación del Hospital Clínico de Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years or more.
  • Diagnosis of Acute Respiratory Distress Syndrome caused by COVID19 infection.
  • Signature of Patient's Consent or Verbal Consent of Legal Representative

Exclusion Criteria:

  • Intracranial hypertension
  • Hypersensitivity to the active ingredient (propofol or sevoflurane) or to any of the excipients
  • Current volume < 250ml
  • History of malignant hyperthermia
  • Liver failure
  • Neutropenia (<0.5x109)
  • Pregnant or lactating women
  • Have received chemotherapy in the last month since their inclusion in the study

Sites / Locations

  • Hospital Universitario Cruces
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario La Paz
  • Hospital Clínico Universitario de Valencia
  • Hospital General Universitario de Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SEVOFLURANE Group

PROPOFOL Group

Arm Description

Outcomes

Primary Outcome Measures

PaO2/FiO2
To evaluate the effect of 48-hour treatment with inhaled sevoflurane on arterial oxygenation, assessed by PaO2/FiO2 on day two, in patients with ARDS-CoVid19

Secondary Outcome Measures

TNFα
To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
IL-1b
To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
IL-6
To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
IL-8
To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
Mortality
To evaluate the 30-day mortality.

Full Information

First Posted
April 21, 2020
Last Updated
July 20, 2021
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT04359862
Brief Title
Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection
Acronym
SEVO-COVID19
Official Title
Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment ratio
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
It is a multicenter, national, randomized 1:1 ratio, controlled, parallel, open study. Patients with severe ARDS-CoVid19 will be included in the trial within the first 24 hours. Patients will be randomized to one of the treatment groups: SEV group: 25 patients with Sevoflurane sedation by inhalation, starting at 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved (BIS 40-50) PRO group: 25 patients standard sedation with intravenous propofol, starting with 2 mg/kg/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, COVID19 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, national, randomized, 1:1 ratio, controlled, parallel, open study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SEVOFLURANE Group
Arm Type
Experimental
Arm Title
PROPOFOL Group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
25 patients sedated with Sevoflurane via inhalation, starting with 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
25 patients standard sedation with intravenous propofol, starting with 2 mg/kg/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)
Primary Outcome Measure Information:
Title
PaO2/FiO2
Description
To evaluate the effect of 48-hour treatment with inhaled sevoflurane on arterial oxygenation, assessed by PaO2/FiO2 on day two, in patients with ARDS-CoVid19
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
TNFα
Description
To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
Time Frame
Day 2
Title
IL-1b
Description
To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
Time Frame
Day 2
Title
IL-6
Description
To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
Time Frame
Day 2
Title
IL-8
Description
To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
Time Frame
Day 2
Title
Mortality
Description
To evaluate the 30-day mortality.
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or more. Diagnosis of Acute Respiratory Distress Syndrome caused by COVID19 infection. Signature of Patient's Consent or Verbal Consent of Legal Representative Exclusion Criteria: Intracranial hypertension Hypersensitivity to the active ingredient (propofol or sevoflurane) or to any of the excipients Current volume < 250ml History of malignant hyperthermia Liver failure Neutropenia (<0.5x109) Pregnant or lactating women Have received chemotherapy in the last month since their inclusion in the study
Facility Information:
Facility Name
Hospital Universitario Cruces
City
Barakaldo
State/Province
Bizkaia
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection

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